Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- MXQStent, Urethral, External Sphincter, Permanent3Product Code
- NAZStimulator, BladderFProduct Code
- NCVLithotripter, Shockwave (For Treating Gallbladder Stones)3Product Code
- QGGEsophageal Sheath With Distal Balloon Anchor2Product Code
- QJNLaparoscopic Accessories, Esophageal Sizing2Product Code
- QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia2Product Code
- EZZProsthesis, Vas Deferens3Product Code
- FAAReplacer, Urethral3Product Code
- FABReplacer, Ureteral3Product Code
- FACValve, Ureterovesicle3Product Code
- FAGProsthesis, Urethral Sphincter3Product Code
- FAODevice, Cystometric, Air3Product Code
- FBYCooler, Esophageal And Gastric3Product Code
- FBZCooler, Prostatic3Product Code
- LEIImplant, Anti-Gastroesophageal Reflux3Product Code
- LILMonitor, Penile TumescenceUProduct Code
- K061676RIGIDOMETER, MODEL DIR-4UUCleared 510(K)
- K062042PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)UCleared 510(K)
- K052929PREFTEST PROFESSIONAL SUITEUCleared 510(K)
- K033126MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEMUCleared 510(K)
- K000194DIGITAL INFLECTION RIGIDOMETER (DIR)UCleared 510(K)
- K991479VISER PENILE TUMESCENCE MONITORUCleared 510(K)
- K980627NEVA SYSTEMUCleared 510(K)
- K940128CAT-400UL PENILE PLETHYSMOGRAPHUCleared 510(K)
- K936115CAT-600 PENILE PLETHYSMOGRAPHUCleared 510(K)
- K941781RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEMUCleared 510(K)
- K925931RT2 RIGIDITY AND TUMESCENCE TESTUCleared 510(K)
- K880903BARD (R) ESKA ERECTIOMETERUCleared 510(K)
- K875333SURGITEK NPT MONITORUCleared 510(K)
- K870983NOCTURNAL PENILE TUMESCENCE MONITORUCleared 510(K)
- K851646VIBRECTORUCleared 510(K)
- K841879LFT - 212UCleared 510(K)
- K841202DACOMED RIGISCAN SYSTEMUCleared 510(K)
- K833454BIOREM 3000 & 4000UCleared 510(K)
- K832121DACOMED SNAP-GAUGEUCleared 510(K)
- K831251TUMISENSOR 1524UCleared 510(K)
- K831252TUMISTORE RECORDER 1311UCleared 510(K)
- K830221BEDSIDE N.P.T. 9900 - PRINTER 9800UCleared 510(K)
- K830158OREXAS POTENTESTUCleared 510(K)
- K822099BIOREM 2000UCleared 510(K)
- K820615DACOMED SNAP-GAUGEUCleared 510(K)
- K810944PENILE ERECTION MONITORUCleared 510(K)
- LJECatheter, NephrostomyUProduct Code
- LKNSeparator, Automated, Blood Cell And Plasma, TherapeuticUProduct Code
- LKXDevice, Thermal, HemorrhoidsUProduct Code
- LNLStimulator, Electrical For Sperm CollectionUProduct Code
- LNMAgent, Bulking, Injectable For Gastro-Urology Use3Product Code
- LNQIntestinal StimulatorFProduct Code
- LNRSystem, Photopheresis, Extracorporeal3Product Code
- LOADevice, Testicular Hypothermia3Product Code
- LQQColumns, Immunoadsorption In Extracorporeal Systems3Product Code
- LQSSpermatocele, AlloplasticUProduct Code
- LRLCushion, HemorrhoidUProduct Code
- LSTDevice, Erectile DysfunctionUProduct Code
- LTIImplant, Intragastric For Morbid Obesity3Product Code
- LXWColumn, Adsorption, Low Density, Lipoprotein3Product Code
- MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma3Product Code
- MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy3Product Code
- MERStent, Urethral, Prostatic, Permanent Or Semi-Permanent3Product Code
- MESStent, Urethral, Bulbous, Permanent Or Semi-Permanent3Product Code
- MIKDevice, Ultrasonic, Thermal Ablation3Product Code
- MIPImplanted Fecal Incontinence Device3Product Code
- MMYLipoprotein, Low Density, Removal3Product Code
- MOAAnalyzer, Diagnostic, Fiber Optic (Colon)3Product Code
- MRESolution, Sodium Hyaluronate3Product Code
- NZCStent, Urethral, Prostatic, Semi-Permanent3Product Code
- OAYLight Source System, Diagnostic Endoscopic3Product Code
- OCKTransurethral Occlusion Insert, Urinary Incontinence-Control, Female3Product Code
- ODHImplantable Bladder-Evacuation Electrical Stimulation SystemFProduct Code
- OKNHyperthermia System, Bladder Cancer Treatment, With Chemotherapy3Product Code
- OVLHemodialyzer, High Cut-OffFProduct Code
- OYFAspiration Therapy System3Product Code
- PATBladder SystemFProduct Code
- PAZElectrical Stimulation Bladder SystemFProduct Code
- PBNApheresis For Focal Glomerulosclerosis In Adult And Pediatric PatientsFProduct Code
- PDIBeta 2-Microglobulin Apheresis ColumnFProduct Code
- PFEGastrointestinal Liner SystemNProduct Code
- PHNProtective Coating, Mucoadhesive Application, For The Rectal MucosaUProduct Code
- PHONormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs3Product Code
- PIKMetabolic Neuromodulation SystemNProduct Code
- PIMNeuromodulator For Obesity3Product Code
- PMHMechanical Compression Device Fecal Incontinence (Non-Manually Operated)FProduct Code
- QBANormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation3Product Code
- QLOImmunoadsorption Column For Emergency UseNProduct Code
- QMKExtracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During Public Health EmergenNProduct Code
- QNBPlasma Processing System For Converting Alpha To Pre-Beta High-Density LipoproteinFProduct Code
- QQKNormothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation3Product Code
- QRHCatheter, Balloon, Urethral, Drug-Coated3Product Code
- QPTStimulator, Tibial, Electrical, Implantable, For Urinary Incontinence3Product Code
- QSWEndoscopic Traction Device2Product Code
- QTDEndoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss2Product Code
- QTHEndoscopic Light-Projecting Measuring Device2Product Code
- QTNOrally Ingested Transient Device For Constipation2Product Code
- QUDBlood Detection Capsule2Product Code
- QUNTether Accessory For Use In The Gastrointestinal Tract2Product Code
- QWWNon-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.2Product Code
- QXHGallbladder Drainage Stent And Delivery System2Product Code
- QXMImplanted Tibial Electrical Urinary Continence Device2Product Code
- QEJFlushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries2Product Code
- QXBDrug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia3Product Code
- QZFGastrointestinal Capsule Endoscopy Analysis Software Device2Product Code
- SAKSoftware Device To Aid In The Prediction Or Diagnosis Of Sepsis2Product Code
- SCBDeflation Needle For Removal Of Intragastric Balloon2Product Code
- QNAUltrasonic Urinary Stone Propulsion Device2Product Code
- SDQAlfapump System3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BIOREM 3000 & 4000
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K833454
- 510(k) Type
- Traditional
- Applicant
- BIOREM
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/21/1984
- Days to Decision
- 146 days